Laser Acupuncture for Pain Prevention in Neonates

Not Applicable

Completed

• Conditions: Pain
• Interventions: Procedure: active laser acupuncture; Procedure: placebo laser acupuncture

• Registration Number: NCT00528125
• Lead Sponsor: University Children Hospital Homburg

Brief Summary

Pain prevention and/or therapy in neonates is still a challenge. It is widely accepted that early pain experience can have a tremendous impact on the pain memory. We want to investigate if a simple, fast method, that is nearly devoid of side effects can lead to a significant alleviation of pain sensation in neonates. Acupuncture has been shown to be effective in various painful conditions. Trials on acupuncture in children are rare. Trials on acupuncture in neonates are lacking so far. Our hypothesis is that neonates in the active laser group experience less pain than those in the placebo group.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-11
• Study First Submitted QC: 2007-09-11
• Study First Posted: 2007-09-12
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2008-03
• Last Update Submitted: 2018-03-27
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Neonates with no obvious underlying disease (genetic (e.g. M. Down), metabolic)and not under pain medication

Exclusion Criteria

• Older than 28 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	active laser acupuncture	Active laser acupuncture
B	placebo laser acupuncture	placebo laser acupuncture

Primary Outcome Measures

Name	Time	Method
The Pain score Premature Infant Pain Profile (PIPP), according to video analysis	5 minutes from the heel prick	The Premature Infant Pain Profile (PIPP Score) is a reliable instrument to measure acute pain in neonates and it includes objective vital parameters and is not only a third-party observation. A total of seven indicators are measured: Three behavioural indicators (facial actions: eye squeeze, brow bulge and nasolabial furrow), two physiological indicators (heart rate and oxygen saturation), and two contextual indicators (gestational age and behavioral state). A scoring of 0, 1, 2 or 3 points is used for each of the seven indicators. All indicators are summed up to a total score. Depending on the gestational age, the possible total score ranges from 18 to 21.

Secondary Outcome Measures

Name	Time	Method
Cry Time	right after after heel prick up to 5 minutes	in seconds (according to the Audio track of the video analysis)

Trial Locations

Locations (1)

University Children Hospital Homburg; 🇩🇪 Homburg, Saarland, Germany